PROMIS Going Global: Challenges and Opportunities · PROMIS Going Global: Challenges and Opportunities Jordi Alonso MD, PhD Director, Epidemiology & Public Health Research Program

PROMIS Going Global: Challenges and Opportunities

Jordi Alonso MD, PhD

Director, Epidemiology & Public Health Research Program IMIM- Hospital del Mar Institute of Medical Research, Barcelona, Spain.

PHO Conference: Measuring Health Outcomes Around the World October 23 & 24, 2016 Copenhagen, Denmark

Contents of this presentation

o Work done - translations and (a lot) more

o The PROMIS International Committee

o Challenges - Science & Implementation

o International Opportunities

2

PROMIS Translations

• PROMIS® Instrument Development and Validation Scientific Standards. 2013; 66-72.

• Havermann L et al. Dutch–Flemish translation of nine pediatric item banks… Qual Life Res (2016) 25:761–65.

Cross-cultural adaptationoHarmonization across languagesUniversal approach to translation

3

PROMIS Translations

PROMIS Translations – Available (adults)

5

Domains LanguagesAny 24Fatigue 21Pain Interference 17Physical Function 15E.D. Depression 12Sleep 13Global health 8E.D. Anxiety 7Social Roles (Ability) 5PROMIS-29 5

6

Philadelphia, November 2012

Language Total Mill. SpeakersSpanish 39 472Dutch 19 21German 10 95Chinese Trad./Simpl. 13 900Portuguese-Br 6 215French 6 80Italian 6 65Russian 4 150Hungarian 4 13Danish 3 5.5Japanese 3 130

PROMIS Translations – Available (adults)

PRISM - PROMIS International Standards and Measures

Possible new objective:o PROMIS 57 or PROMIS 29 profile items in as many

languages as possibleo selected short forms to as many languages as possible

7

PROMIS Translations - More

!! Don’t miss Plenary # 4 at 14:00 tomorrow (with: Helena Correia)

Dutch-Flemish PROMISTranslationso 17 item banks for adults translated paper publishedo 9 item banks for children translated paper published

Funding: Dutch Arthritis Association.

Validationso 15 validation studies ongoing using whole item banks

5 papers published, 3 submittedo 1 responsiveness study using CATs underwayo 3 validation study using SFs underway.

Funding: D. Physiotherapy & D. Arthritis Associations & D. Asthma Foundation

8

Dutch-Flemish PROMISDutch calibrations & Norming:o Dutch gen. population (8+Global Health) (n=1,000)o Adolescents (Sleep) (n= 1,000)o SFs PROMIS Profile-29 general population cohort

“Lifelines” (150,000 adults, end of 2015).Implementation:o 51 short forms, PROMIS Profile-29: availableo 18 studies using SFs, o Routine assessment: 1 using Profile-29, one, CAT.

Publications: 10 + 3 (submitted)9

Dutch-Flemish PROMIS

10

www.dutchflemihspromis.nl

http://www.dutchflemihspromis.nl/

PROMIS International Committee

11


PROMIS – International Committee

12


• Mission Statement approved (PHO BOD)• 2 international members in the PHO BOD

PROMIS International Committee (PIC)

13

16 Countries: Australia, Canada, Denmark, Finland, France, Germany, Hong Kong (China), Hungary, Italy, Japan, the Netherlands, Poland, Spain, Sweden, UK, USA


14


Your institution (or your role in it) is mostly: (n=17)


15


What types of PROMIS methodological studies have been done/are currently being carried out in you country

–yours of others (check all that apply):


16


Is there any PROMIS group (i.e., a formal network of PROMIS researchers and/or users) in your country?


17


What are the most important barriers/difficultiesfor PROMIS development/growth in your country?

• Funding for translations/validation/… • Translations and evidence of metric properties • Availability of national Assessment Centre(s) and CATs• Entrenched use of legacy or unstandardized measures• Confusions/Lack of Awareness: access & use; PROMIS

an off-the-shelf system to capture and display longitudinal PRO data

• Low acceptability of soft outcomes in some cultures/countries

• Rapid growth in the US


18


Please indicate current and specific needs for PROMIS development/growth in your country

• Developing evidence of metric properties• Translation/validation & distribution service delivery in

place

• Prioritize item banks and SFs• Coordination (translation/queries from users)• Increase awareness of benefits: clinical practice &

registries; regulatory agencies (FDA,CMS) researchers/users

• More support from Healthmeasures.net

International issues:

19


Translations – Scientific Standards

20

Calibration & Validation Standards

21

Country Calibration Studies: • Assessing language DIF• Model replication

Country Validation Studies: • Setting • Sample Sizes• Initial• Advanced (Responsiveness and MID)

PROMIS Metric

22

)20 30 40 50 60 70 80 20 30 40 50 60 70 80 68%

95%

99.7%

50 = mean for the US populationstandard deviation = 10

Any mental disorder (12-month) in the WMH surveys

0 5 10 15 20 25 30 35

Nigeria

Italy

Romania

Japan

Israel

Spain

Bulgaria

Germany

China

Iraq

Mexico

Belgium

Netherlands

South Africa

Lebanon

India (Pondich)

Colombia

France

Ukraine

New Zealand

Portugal

North Ireland

US

Brazil

WHO African Region

WHO Region of the Americas

WHO South-East Asia Region

WHO European Region

WHO Eastern Mediterranean Region

WHO Western Pacific Region

Gráfico2

Nigeria

Italy

Romania

Japan

Israel

Spain

Bulgaria

Germany

China

Iraq

Mexico

Belgium

Netherlands

South Africa

Lebanon

India (Pondich)

Colombia

France

Ukraine

New Zealand

Portugal

North Ireland

US

Brazil

6.2

8.4

8.7

9.3

10.3

10.7

11.1

12.9

13

13.6

13.8

15.2

15.3

17.2

19.1

20.2

21.1

21.2

21.4

23.6

24.7

25.7

30.9

31.5

tot

ctrctr3MDEPanic DisAlcohol DisPTSDAny Disorderratefm_MDEratefm_Alcrate_fm_AnyServices_MDEServices_ANYSevereModerateMildpmsev_1pmsev_2pmsev_3pfsev_1pfsev_2pfsev_3ctr4Adjnetsav00Adjnetsav05Adjnetsav06Adjnetsav07Adjnetsav08Educexp00Educexp05Educexp06Educexp07healthexp05healthexp06healthexp07GDP_capita_2000GDP05GDP06GDP07GDP08GenderIIupd08GenderII08HDI_2000HDI_2005HDI_2006HDI_2007HDI_2008HomicR08yschool00yschool05yschool06yschool07yschool08yschool09yschool10GINI_2010GINI_yearAlcCons04FishCons00SuicR_yearSuicR_maleSuicR_femSuicRReligionReligion2RespRateCAPI_PAPICAPIyear_inicyear_finsamplinLevNationallyRewardingP2samplesizeanyAdjnetsavEducexpHealthexpGDPHDIyschool

16Nigeria1.10.10.706.21.100.863636363617.910.70.80.84.61.20.84.60.40.84.6Nigeria.........1.91.81.715761880195020272099...0.4020.410.4120.4161.37.58.98.98.98.98.98.943.7200310.046.57....MuslimMuslim79.3PAPI020022003states0present167522000..1.915760.4027.5

10Italy2.90.60.20.68.42.41176470590.33333333332.755555555641.227.91.343.10.81.91.81.76.24.4Italy9.588.48.68.64.54.44.74.36.86.96.730665311413159531855312830.2510.2510.8250.8380.8440.8480.851.215.11616.216.316.316.316.33220069.1422.5720069.92.86.35ChristianCatholic71.3CAPI120012002NR1present1471220009.54.56.8306650.82515.1

21Romania1.70.410.98.71.53846153850.051.059523809527.319.32.22.542.324.12.12.93.9Romania2.54.76.610.113.72.93.5.4.43.83.53.87806106861155512272134490.4860.4780.690.7330.7430.7540.7652.21213.51414.314.814.814.83220087.632.63200718.9411.45ChristianProtestant70.9CAPI120052006NR1.0235720054.73.53.8106860.73313.5

11Japan2.80.41.10.89.32.73333333330.21052631581.32534.9201.44.43.61.53.23.21.25.53.9Japan10.88.99.110.615.33.73.53.53.46.76.66.531037328783355334352341290.2730.2730.8550.8730.8770.880.8810.514.514.91515.115.115.115.137.620087.3866.74200735.813.724.75BuddhistBuddhist55.1CAPI120022006MetrAreas0none1412920058.93.56.7328780.87314.9

9Israel6.10.61.30.610.31.52083333330.18181818181.228260869636.229.63.83.533.22.53.54.44.52.4Israel9.714.716.415.211.36.56.26.26.44.64.44.525311255482642627312279050.3320.3320.8420.8610.8640.8690.872.414.915.415.415.615.615.615.639.220081.9920.0720058.73.36JewishJewish72.6CAPI120022004NR1none04859200514.76.24.6255480.86115.4

23Spain4.10.60.90.610.72.3750.05882352941.905405405459.530.91.94.64.20.92.63.92.96.64.6Spain12.210.810.39.610.14.34.24.34.45.866.128014305203119031783316740.280.280.8280.8480.8520.8570.8610.915.9161616.216.416.416.432200512.2543.272005123.87.9ChristianCatholic78.6CAPI120012002NR1present15473200012.24.35.8280140.82815.9

3Bulgaria20.61.4111.12.63636363640.161.581395348833.219.71.83.75.61.32.94.42.24.66.8Bulgaria0.52.5-0.51.72.9.4.54.24.14.74.14.2717296671037411070117920.4120.3990.6930.7240.7290.7360.7412.31313.413.413.713.713.713.729.820087.133.11200419.76.713.2ChristianProtestant72PAPI020032007NR1.1531820052.54.54.796670.72413.4

7Germany3.50.91.40.812.91.65384615380.21739130431.263157894745.724.22.85.34.83.14.24.22.46.45.5Germany8.712.413.915.7.4.54.54.4.8.28.1832099329673398134864353740.240.24.0.8780.8810.8830.8850.8.15.615.615.615.615.615.627200612.8913.74200617.9611.95Christian.57.8CAPI120022003NR1none1355520008.74.58.2320990.87815.6

4China30.20.60.2131.03333333330.08333333330.904411764784.214.27.70.94.58.1147.3China23.736.338.538.135.1....1.81.91.9288544134898550659710.3930.4050.5670.6160.6270.6390.6481.29.710.710.911.211.411.411.441.520074.4524.5119991314.813.9BuddhistBuddhist77.77PAPI020022007MetrAreas0none112333200536.3.1.844130.61610.7

8Iraq3.910.10.913.61.655172413801.4818181818116.72.94.95.81.74.15.34.25.86.3Iraq........32.51.9.....0.6930.751......8.59.79.79.79.79.79.7..0.2.....MuslimMuslim95.2PAPI020062007NR1.043322006..2.5..9.7

13Mexico3.90.72.20.613.82.120.04651162791.264462809923.1153.54.75.63.92.95.236.35.9Mexico11.31010.91194.954.84.82.72.62.713119136531415514462145700.5960.5760.6980.7270.7350.7420.74511.612.11313.213.413.413.413.448.220084.6210.0120066.81.34.05ChristianCatholic76.6CAPI120012002UrbanAreas0none15782200011.34.92.7131190.69812.1

1Belgium5.71.12.2115.21.59090909090.25714285711.211678832152.437.24.95.94.44.45.83.65.46.15.1Belgium12.613.61515.8..666.17.47.2731757336673444535136352380.2360.2360.8630.8580.8610.8640.8651.818.215.915.915.915.915.915.928200510.0624.25199927.29.518.35ChristianCatholic50.6CAPI120012002NR1none12419200012.667.4317570.86318.2

15Netherlands5.41.32.3315.32.406250.39393939393.039473684250.531.24.64.75.92.72.42.46.67.19.4Netherlands15.614.217.818.6-1.255.55.5.5.97.47.336271377933900640268409610.1740.1740.8680.8770.8820.8860.888116.516.416.516.616.716.716.730.920079.7421.62200711.658.3NoneNone56.4CAPI120022003NR1present12372200015.655.9362710.86816.5

22South Africa50.85.10.717.22.12903225810.27380952381.066265060215.819.24.45.47.54.13.88.74.66.76.4South Africa4.82.82.21.2-3.55.65.45.45.33.53.63.68117920795959987101160.6370.635.0.5870.5880.590.59236.5.13.413.413.413.413.413.46520057.816.12....ChristianProtestant87.1PAPI020032004NR1none0431520052.85.43.592070.58713.4

12Lebanon5.70.20.62.219.11.92307692310.44444444442.015873015919.794.48.16.635.545.810.59.1Lebanon-11.7-4.52.67.20.122.62.82.63.743.9926810315102641093611777......0.612.112.713.213.413.513.513.5..4.136.29....MuslimMuslim70PAPI020022003NR1psychConsult128572000-11.723.79268.12.1

19India (Pondich)4.50.95020.22.03333333330.03157894741.15508021397.654.27.88.274.86.91.410.79.5India14.621.5232524.24.43.23.2.111.1186024192616281529460.7210.7480.440.4820.4910.50.5062.88.49.910.110.310.310.310.336.820040.824.47199812.29.110.65HinduHindu98.8PAPI020032005NR1.12992200521.53.2124190.4829.9

5Colombia6.20.72.50.621.11.8809523810.081.13265306122112.84.98.67.66.276.53.8108.5Colombia-145.43.91.53.743.94.15.35.25.1696678008217870687970.6360.6580.6370.6580.6670.6760.68138.811.612.512.913.113.313.313.358.520095.924.8520057.82.14.95ChristianCatholic87.7CAPI120032003UrbanAreas0present144262000-13.75.369660.63711.6

6France6.711.62.721.21.57692307690.10344827591.813333333348.428.649.47.83.85.16.24.213.79.4France13.910.811.311.79.85.75.65.6.8.88.78.730690322093266133102330580.260.260.8340.8560.860.8640.8671.415.616.216.216.216.116.116.132.7200813.5430.81200625.5917.25ChristianCatholic45.9CAPI120012002NR1present12894200013.95.78.8306900.83415.6

24Ukraine7.31.27.12.221.42.34883720930.12977099240.885964912315.312.25.27.38.86.75.2113.99.36.9Ukraine-2.51011.511.88.54.26.16.25.33.83.94400260456531708972770.4880.4630.6490.6960.7030.710.7146.312.914.214.414.614.614.614.63120064.0413.01200540.9723.95ChristianProtestant78.3PAPI020022002NR1cash147252000-2.54.23.840020.64912.9

18New Zealand7.51.93.43.323.61.64285714290.41666666671.3857868025634.66.19.585.87.66.36.411.49.5New Zealand8.38.77.2...6.56.26.26.77.27.123983271142727727828272600.3460.320.8650.8960.8980.9030.9031.317.419.419.419.719.719.719.736.219979.7922.59200518.96.312.6NoneNone73.3CAPI120032004NR1present11279020058.76.56.7271140.89619.4

20Portugal8.1122.324.72.63636363640.18181818181.718232044256.2344.112.87.72.39.66.26169.2Portugal6.21.80.61.44.15.45.45.3.7.37.17.122405226852291923295232540.3030.310.7740.7750.7780.7850.7891.215.915.315.215.515.515.515.538.5200712.4954.25200417.95.511.7ChristianCatholic57.3CAPI120082009MetrAreas0.1384920084.15.37.1232540.78915.5

17North Ireland10.22.63.65.325.72.12307692310.3584905661.155462184951.137.47.68.69.56.47.5108.79.79Nireland14.7514.7515.213.95.74.455.155.25.256.156.26.532444.53743038454.539640386590.35650.34950.8390.86550.86650.87050.87153.416.417.116.8516.916.916.916.931.65200712.4222.13200713.753.38.525Christian.68.4CAPI120042007NR1.14340200514.755.156.15374300.865517.1

14US9.33.13.74.230.91.65714285710.41509433961.215827338153.635.47.912117.29.710.98.714.211United States9.44.76.15.50.9.5.45.75.56.977.142359452934611446590463500.4570.40.8930.8950.8970.8990.95.215.215.715.615.715.715.715.74520078.5121.66200517.74.511.1ChristianProtestant70.9CAPI120022003NR1cash1928120009.45.46.9423590.89315.2

2Brazil10.91.13.41.731.52.3593750.22807017541.708695652232.520.210.610.210.78.56.28.412.613.812.9Brazil4.17.67.67.45.244.555.23.33.53.58576920994689902103040.5960.6310.6490.6780.6810.6850.692214.514.21413.813.813.813.856.720055.326.0320057.31.94.6ChristianCatholic81.3PAPI020052007NR1.1503720057.64.53.392090.67814.2

&A

Page &P

Any Dis

Any Dis

Nigeria

Italy

Romania

Japan

Israel

Spain

Bulgaria

Germany

China

Iraq

Mexico

Belgium

Netherlands

South Africa

Lebanon

India (Pondich)

Colombia

France

Ukraine

New Zealand

Portugal

North Ireland

US

Brazil

6.2

8.4

8.7

9.3

10.3

10.7

11.1

12.9

13

13.6

13.8

15.2

15.3

17.2

19.1

20.2

21.1

21.2

21.4

23.6

24.7

25.7

30.9

31.5

MDE

MDE

Nigeria

Italy

Romania

Japan

Israel

Spain

Bulgaria

Germany

China

Iraq

Mexico

Belgium

Netherlands

South Africa

Lebanon

India (Pondich)

Colombia

France

Ukraine

New Zealand

Portugal

North Ireland

US

Brazil

MDE

1.1

2.9

1.7

2.8

6.1

4.1

2

3.5

3

3.9

3.9

5.7

5.4

5

5.7

4.5

6.2

6.7

7.3

7.5

8.1

10.2

9.3

10.9

Panic Dis

Panic Dis

Nigeria

Italy

Romania

Japan

Israel

Spain

Bulgaria

Germany

China

Iraq

Mexico

Belgium

Netherlands

South Africa

Lebanon

India (Pondich)

Colombia

France

Ukraine

New Zealand

Portugal

North Ireland

US

Brazil

0.1

0.6

0.4

0.4

0.6

0.6

0.6

0.9

0.2

1

0.7

1.1

1.3

0.8

0.2

0.9

0.7

1

1.2

1.9

1

2.6

3.1

1.1

Alcohol Dis

Alcohol Dis

Nigeria

Italy

Romania

Japan

Israel

Spain

Bulgaria

Germany

China

Iraq

Mexico

Belgium

Netherlands

South Africa

Lebanon

India (Pondich)

Colombia

France

Ukraine

New Zealand

Portugal

North Ireland

US

Brazil

0.7

0.2

1

1.1

1.3

0.9

1.4

1.4

0.6

0.1

2.2

2.2

2.3

5.1

0.6

5

2.5

1.6

7.1

3.4

2

3.6

3.7

3.4

RATE

RATE

NigeriaNigeria

ItalyItaly

RomaniaRomania

JapanJapan

IsraelIsrael

SpainSpain

BulgariaBulgaria

GermanyGermany

ChinaChina

IraqIraq

MexicoMexico

BelgiumBelgium

NetherlandsNetherlands

South AfricaSouth Africa

LebanonLebanon

India (Pondich)India (Pondich)

ColombiaColombia

FranceFrance

UkraineUkraine

New ZealandNew Zealand

PortugalPortugal

North IrelandNorth Ireland

USUS

BrazilBrazil

ratefm_MDE

ratefm_Alc

1.1

0

2.4117647059

0.3333333333

1.5384615385

0.05

2.7333333333

0.2105263158

1.5208333333

0.1818181818

2.375

0.0588235294

2.6363636364

0.16

1.6538461538

0.2173913043

1.0333333333

0.0833333333

1.6551724138

0

2.12

0.0465116279

1.5909090909

0.2571428571

2.40625

0.3939393939

2.1290322581

0.2738095238

1.9230769231

0.4444444444

2.0333333333

0.0315789474

1.880952381

0.08

1.5769230769

0.1034482759

2.3488372093

0.1297709924

1.6428571429

0.4166666667

2.6363636364

0.1818181818

2.1230769231

0.358490566

1.6571428571

0.4150943396

2.359375

0.2280701754

Freq MDE

Freq MDE

Nigeria

Italy

Romania

Japan

Israel

Spain

Bulgaria

Germany

China

Iraq

Mexico

Belgium

Netherlands

South Africa

Lebanon

India (Pondich)

Colombia

France

Ukraine

New Zealand

Portugal

North Ireland

US

Brazil

17.9

41.2

27.3

34.9

36.2

59.5

33.2

45.7

8

11

23.1

52.4

50.5

15.8

19.7

7.6

21

48.4

15.3

56

56.2

51.1

53.6

32.5

Country Specific Norms

24

Don’t miss Plenary # 4 at 14:00 tomorrow(with: Martine Crins; & Matthias Rose)

Translations – Practical issues

• US:– All distribution rights on PHO– NIH legal coverage– No charges allowed for U.S. English/ U.S.

Spanish within the U.S.– NIHPROMIS web site; Assessment Center

• Internationally:– Translations Derivative Products with IP rights– Ownership rights transferred to the PHO– PROMIS National Centers (PNCs)

25

PROMIS® National Centers

Mission: – facilitate translation and adoption of PROMIS

methods and tools internationally– make PROMIS tools available for academic,

scientific & clinical communities at low/no cost• distribution rights• cost recovery policy• quality control of IRT parameters

26

PROMISing global initiatives:

27


ORGANISATIONSNAMN (ÄNDRA SIDHUVUD VIA FLIKEN INFOGA-SIDHUVUD/SIDFOT)

• Variables - Disease-specific data– disease management (diagnosis, clinical characteristics, treatment

and lead times). – Lifestyle (smoking) and General Health Status (World Health

Organization performance status, body mass index and blood pressure).

• Patient-reported outcome measures– Patient satisfaction is recorded in 23 QRs, with even

more recording other types of PROMs, including the EQ5D (n = 46) and SF-36 (n = 14)

– national e-Health

More info John Chaplin, PhD, Plenary later today at 4:45 pm!

Our current 21 Standard Sets

PROMIS Going Global: Challenges and Opportunities

Jordi Alonso MD, PhD

Director, Epidemiology & Public Health Research Program IMIM- Hospital del Mar Institute of Medical Research, Barcelona, Spain.

PHO Conference: Measuring Health Outcomes Around the World October 23 & 24, 2016 Copenhagen, Denmark

Thank you!

PROMIS Going Global: Challenges and OpportunitiesContents of this presentationPROMIS TranslationsSlide Number 4PROMIS Translations – Available (adults)Slide Number 6PRISM - PROMIS International Standards and MeasuresDutch-Flemish PROMISDutch-Flemish PROMISDutch-Flemish PROMISPROMIS International CommitteePROMIS – International CommitteePROMIS International Committee (PIC)PROMIS International Committee (PIC)PROMIS International Committee (PIC)PROMIS International Committee (PIC)PROMIS International Committee (PIC)PROMIS International Committee (PIC)International issues: Translations – Scientific StandardsCalibration & Validation StandardsPROMIS MetricSlide Number 23Country Specific NormsTranslations – Practical issuesPROMIS® National Centers PROMISing global initiatives: Slide Number 28Slide Number 29Slide Number 30Slide Number 31Slide Number 32PROMIS Going Global: �Challenges and Opportunities

Documents

PROMIS Going Global: Challenges and Opportunities · PROMIS Going Global: Challenges and Opportunities Jordi Alonso MD, PhD Director, Epidemiology & Public Health Research Program